Sumatriptan 5mg Nasal Spray(6 Spr)

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B/1D) receptors. It is believed to exert its antimigraine effects by causing vasoconstriction of intracranial blood vessels, particularly those of the carotid arterial circulation, and by inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Seizures
Loss of eyesight (which can be long-lasting)
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Discoloration of the skin, lips, nail beds, fingers, or toes (blue or gray)
Gastrointestinal issues, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Cramps and pain in legs or hips
+ Feeling of heaviness or tightness in the leg muscles
+ Feeling cold
+ Burning or aching pain in the feet or toes

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor immediately:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Brain Blood Vessel Problems: A Rare but Serious Condition

In rare cases, this medication can cause brain blood vessel problems, including stroke. If you experience any of the following symptoms, contact your doctor immediately:

Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Changes in eyesight

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
Vomiting
Changes in taste
Burning sensations
Nose or throat irritation

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ High blood pressure
+ Liver disease
A history of specific health problems, such as:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, including hemiplegic or basilar migraines
+ Abnormal heart rhythms, such as Wolff-Parkinson-White syndrome
Recent use of certain antidepressant medications, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
Concurrent use of another medication containing the same active ingredient.
Use of other medications for migraines, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours.
* Use of ergotamine, methysergide, dihydroergotamine, or similar medications within the last 24 hours.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Precautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before engaging in activities that require alertness, such as driving, wait until you understand how this medication affects you.

Monitor your blood pressure regularly, as prescribed by your doctor, because this medication can cause high blood pressure.

Note that this medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is different from your typical migraine, consult your doctor before taking this medication.

Be cautious not to exceed the dosage prescribed by your doctor, as taking more of this medication than recommended can worsen your headaches.

If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking, being a male over 40 years old, having a family history of early heart disease, or being a postmenopausal female, exercise caution and discuss these risks with your doctor.

Although rare, this medication can cause severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, within a few hours of taking it. Seek immediate medical attention if you experience symptoms such as chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; cold sweats; shortness of breath; rapid or irregular heartbeat; or severe dizziness or fainting.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Special Considerations for Children

This medication is not approved for use in children. However, your doctor may determine that the benefits of taking this medication outweigh the risks for your child. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.

• Monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs
• Ergot-type medications (e.g., ergotamine, dihydroergotamine) or within 24 hours of sumatriptan
• Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan

• SSRIs/SNRIs (risk of serotonin syndrome)
• St. John's Wort (risk of serotonin syndrome)

• Propranolol (may increase sumatriptan levels, though not clinically significant for oral sumatriptan, caution with nasal)
• Cimetidine (may increase sumatriptan levels)

• Chest pain or tightness
• Jaw or neck tightness/pain
• Dizziness
• Tingling/numbness (paresthesia)
• Warm sensation
• Flushing
• Nasal discomfort/irritation
• Unusual taste
• Signs of serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, nausea, vomiting, diarrhea)
• Signs of allergic reaction (rash, hives, swelling, difficulty breathing)

Use only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but animal studies show some developmental toxicity at high doses.

Sumatriptan is excreted into breast milk. Infant exposure is low. Consider avoiding breastfeeding for 12 hours after a dose to minimize infant exposure, or use an alternative triptan with less milk transfer.

Safety and efficacy not established in patients under 18 years of age. Not recommended for pediatric use.

Use with caution due to higher prevalence of cardiovascular disease and potential for decreased renal/hepatic function. Consider lower initial doses and careful monitoring.

• Sumatriptan nasal spray is effective for acute treatment of migraine and cluster headaches, offering a faster onset of action than oral forms.
• It is crucial to rule out underlying cardiovascular disease before initiating sumatriptan due to its vasoconstrictive effects.
• Patients should be advised to use the nasal spray at the first sign of a headache attack, but not for prevention.
• Counsel patients on the proper administration technique for nasal spray to ensure optimal absorption and efficacy.
• Warn patients about the potential for serotonin syndrome when co-administered with SSRIs, SNRIs, or other serotonergic drugs.
• Do not use within 24 hours of other triptans or ergotamine-containing medications.

• Other triptans (e.g., zolmitriptan nasal spray, rizatriptan, eletriptan, frovatriptan, naratriptan)
• CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
• Ditans (e.g., lasmiditan)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Ergotamine/dihydroergotamine (for severe, refractory migraines)
• Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.